Sarecycline (sar-e-SYE-kleen)

Treats moderate to severe acne. This medicine is a tetracycline antibiotic.

Brand Name(s):

Seysara

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your acne may not clear up if you stop using the medicine too soon.
• Drink plenty of fluids to avoid throat irritation and ulceration.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sarecycline works. Tell your doctor if you are using any of the following:
  • Digoxin, penicillin
  • Blood thinner (including warfarin)
  • Medicine that contains aluminum, bismuth subsalicylate, calcium, magnesium, or iron (including an antacid or vitamin supplement)
  • Oral retinoid medicine (including acitretin, isotretinoin)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have diarrhea or eye or vision problems.
• This medicine may cause the following problems:
  • Slow bone growth or permanent change in tooth color (in children 8 years of age and younger)
  • Increased pressure inside the head
• This medicine may cause dizziness, lightheadedness, or spinning feeling. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other change in vision
• Increased sensitivity of the skin to sunlight, severe sunburn or skin rash
• Severe diarrhea that is watery or bloody
• Severe headache, dizziness

If you notice these less serious side effects, talk with your doctor:

• Lightheadedness, feeling of spinning

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088